Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs (MEMBRAN)

Masquelet's induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. The particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). The presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery).

In view of the excellent clinical results obtained with this procedure, the Masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery.

However, orthopedic surgeons sometimes observe failures in bone consolidation. To our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Clamart, France, 92140
      • Saint-Mandé, France, 94160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient with traumatic bone loss
  • Patient eligible for the induced membrane technique

Exclusion Criteria:

  • Patients with post-tumor bone loss
  • Patients who are immunocompromised or under immunosuppressive treatment
  • Patients with chronic inflammatory disease (diabetes, inflammatory bowel disease)
  • Patients with collagenosis
  • Patient with a contraindication to sampling
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological profile of induced membrane fragments
Time Frame: Through study completion, an average of 6,5 years
Presence of abnormalities in the organization of connective fibers. The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.
Through study completion, an average of 6,5 years
Cellular profile of induced membrane fragments
Time Frame: Through study completion, an average of 6,5 years

Presence of mesenchymal stromal cells, ability of these cells to differentiate into osteoblasts, presence of other cell types (such as adipocytes and osteoclasts).

The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.

Through study completion, an average of 6,5 years
Secretory profile of induced membrane fragments
Time Frame: Through study completion, an average of 6,5 years

Determination of proteins secreted by the induced membrane fragments by mass spectrometry or by enzyme-linked immunosorbent assay.

The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.

Through study completion, an average of 6,5 years
Gene expression profile of induced membrane fragments
Time Frame: Through study completion, an average of 6,5 years

Expression of several genes of interest related to angiogenesis, mesenchymal stromal cells mobilization, bone formation or resorption and extracellular matrix remodeling.

The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.

Through study completion, an average of 6,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Anticipated)

April 1, 2028

Study Completion (Anticipated)

April 1, 2028

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Estimate)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2019PPRC03
  • 2021-A00561-40 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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